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Hospitalizations for bleeding associated with apixaban versus rivaroxaban according to dose in Medicare beneficiaries 根据医疗保险受益人的剂量,阿哌沙班与利伐沙班相关的出血住院
Q4 Medicine Pub Date : 2025-08-07 DOI: 10.1016/j.tru.2025.100220
Luke S. Vest , Seo H. Baik , Fitsum Baye , Kin-Wah Fung , Clement J. McDonald

Introduction

Apixaban and rivaroxaban are the most prescribed direct oral anticoagulants, and the safety of different doses in patients at high risk for bleeding is not fully defined. The objective of this study was to compare the rate of hospitalizations due to bleeding in patients prescribed apixaban versus rivaroxaban at specific doses.

Methods

We conducted a retrospective cohort study of more than 1.9 million Medicare beneficiaries who filled prescriptions for apixaban or rivaroxaban from 2014 to 2020 using the Medicare Parts A, B, C and D encounter and prescription claims database. The primary outcomes measured were hospitalizations due to bleeding categorized by location (intracranial, gastrointestinal [GI], and other) and all-cause mortality.

Results

Among the population studied, 1,022,170 (53 %) filled a prescription for apixaban 5 mg during the study period, followed by rivaroxaban 20 mg (27 %) and rivaroxaban 10 mg (11 %). Compared to the reference group of apixaban 5 mg, combination prescriptions for rivaroxaban 15–20 mg were associated with more than twice the risk of hospitalization due to GI bleeding (hazard ratio [HR] = 2.41, 95 % confidence interval [CI]: 2.15–2.70) and other bleeding (HR = 2.42, 95 % CI: 1.92–3.05) and were associated with a 51 % higher risk of hospitalization due to intracranial bleeding (HR = 1.51, 95 % CI: 1.15–1.98). There were 88,740 (4.6 %) deaths during the study period, with a 27 % increased risk of death associated with prescriptions for apixaban 2.5 mg (HR = 1.27, 95 % CI: 1.24–1.30) and a 19 % decreased risk of death associated with prescriptions for rivaroxaban 10 mg (HR = 0.81, 95 % CI: 0.78–0.85).

Conclusion

Rivaroxaban doses of 15 mg and greater were associated with higher bleeding risk. This data may aid clinicians in making an informed decision when prescribing specific doses of apixaban and rivaroxaban, particularly for patients with a high risk of bleeding.
阿哌沙班和利伐沙班是处方最多的直接口服抗凝剂,不同剂量对高危出血患者的安全性尚未完全确定。本研究的目的是比较特定剂量阿哌沙班和利伐沙班患者因出血而住院的比率。方法:我们对2014年至2020年期间处方阿哌沙班或利伐沙班的190多万医疗保险受益人进行了回顾性队列研究,使用医疗保险a、B、C和D部分的遭遇和处方索赔数据库。测量的主要结局是因出血(颅内、胃肠道[GI]和其他)和全因死亡率而住院的情况。结果在研究人群中,1,022170人(53%)在研究期间服用阿哌沙班5mg,其次是利伐沙班20mg(27%)和利伐沙班10mg(11%)。与阿哌沙班5 mg对照组相比,联合处方利伐沙班15-20 mg组因胃肠道出血(风险比[HR] = 2.41, 95%可信区间[CI]: 2.15-2.70)和其他出血(HR = 2.42, 95% CI: 1.92-3.05)住院的风险增加了一倍以上,因颅内出血住院的风险增加了51% (HR = 1.51, 95% CI: 1.15-1.98)。在研究期间有88,740例(4.6%)死亡,处方阿哌沙班2.5 mg的死亡风险增加27% (HR = 1.27, 95% CI: 1.24-1.30),处方利伐沙班10 mg的死亡风险降低19% (HR = 0.81, 95% CI: 0.78-0.85)。结论利伐沙班15mg及以上剂量患者出血风险较高。这些数据可以帮助临床医生在处方特定剂量的阿哌沙班和利伐沙班时做出明智的决定,特别是对于出血高风险的患者。
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引用次数: 0
Asymptomatic patients with carotid atherosclerosis present a higher coagulation state compared to healthy subjects 无症状颈动脉粥样硬化患者的凝血状态高于健康人
Q4 Medicine Pub Date : 2025-07-26 DOI: 10.1016/j.tru.2025.100219
Laurie Josset , Mathilde Mura , Mathis Damon , Emma de Cartier d’Yves , Michèle Weiss-Gayet , Anaelle Boreau , Emeraude Rivoire , Nellie Della-Schiava , Anne Long , Sandrine Horman , Antoine Millon , Vincent Pialoux , Amandine Thomas

Background

In pro-inflammatory conditions, such as atherosclerosis, circulating monocytes may express tissue factor (TF), increasing thromboembolic risk. Regular physical activity (PA) has been shown to modulate hemostasis by reducing fibrinogen concentration and platelet activation, though its effects on coagulation are limited.

Objectives

We aim to evaluate the procoagulant and proinflammatory state in asymptomatic patients with atherosclerotic carotid stenosis, compared to healthy subjects and to assess the impact of a 6-month PA intervention.

Methods

This study included patients with asymptomatic carotid stenosis and healthy subjects. Patients were randomized into a PA group (6-month individualized PA intervention), and a control group. Blood analyses were performed to assess monocyte phenotype and TF expression by flow cytometry, and coagulation parameters using rotative thromboelastometry.

Results

The expression of TF on the surface of circulating monocytes was significantly higher in patients than in healthy subjects (61.9 ± 11.7 % vs 33.7 ± 6.3 %, p < 0.0001), mainly explained by a higher expression on classical monocytes (77.7 ± 9.5 vs 58.3 ± 15.8 %, p < 0.001). Clotting times were lower in patients than in healthy subjects in basal (407.8 77.7 ± 144.6 s vs 615.5 ± 123.4 s p < 0.0001) and proinflammatory (222.4 ± 48.2 s vs 307.8 ± 82.4 s p = 0.003) conditions. A 6-month PA intervention did not induce any modulation of the monocyte phenotype or coagulation parameters of patients with atherosclerosis.

Conclusion

Asymptomatic patients with carotid atherosclerosis have a higher proinflammatory and procoagulant profile, suggesting a higher thromboembolic risk. However, home-based PA intervention did not improve their profiles.
背景:在促炎条件下,如动脉粥样硬化,循环单核细胞可能表达组织因子(TF),增加血栓栓塞的风险。有规律的体育活动(PA)已被证明通过降低纤维蛋白原浓度和血小板活化来调节止血,尽管其对凝血的影响有限。目的:我们的目的是评估无症状的动脉粥样硬化性颈动脉狭窄患者的促凝和促炎状态,与健康受试者进行比较,并评估6个月PA干预的影响。方法本研究包括无症状颈动脉狭窄患者和健康受试者。患者被随机分为PA组(6个月个体化PA干预)和对照组。进行血液分析,通过流式细胞术评估单核细胞表型和TF表达,并使用旋转血栓弹性仪评估凝血参数。结果患者外周血单核细胞表面TF表达明显高于正常对照组(61.9±11.7% vs 33.7±6.3%,p <;0.0001),主要原因是在经典单核细胞中表达较高(77.7±9.5% vs 58.3±15.8%,p <;0.001)。患者凝血时间低于健康对照组(407.8±77.7±144.6 s vs 615.5±123.4 s p <;0.0001)和促炎(222.4±48.2 s vs 307.8±82.4 s p = 0.003)。6个月的PA干预没有引起动脉粥样硬化患者单核细胞表型或凝血参数的任何调节。结论无症状颈动脉粥样硬化患者具有较高的促炎和促凝特征,提示血栓栓塞风险较高。然而,以家庭为基础的PA干预并没有改善他们的档案。
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引用次数: 0
Exploring experiences of patients attending an outpatient thrombosis service in Canada 探讨患者参加门诊血栓服务在加拿大的经验
Q4 Medicine Pub Date : 2025-07-14 DOI: 10.1016/j.tru.2025.100218
Gabriela Carrillo-Balam , Tiffany Lee , Stephanie Young

Background

There is limited information on patients' experiences that influence their satisfaction and perception of the quality of care received at comprehensive thrombosis and anticoagulation management services. However, in order to provide patient-centred care, patients’ input is fundamental. Therefore, we aimed to explore the views and experiences of people who received care at an Adult Outpatient Thrombosis Service to identify aspects that are valued as well as areas for improvement.

Methods

This is an analysis of free-text data from an anonymous survey sent to all adult patients who received care from a multidisciplinary Thrombosis Service in Newfoundland and Labrador, Canada between October 2017 and May 2019. Thematic analysis was used to analyze the open-ended free text responses and identify common themes.

Findings

In total, 40.7 % (n = 229) of survey respondents (N = 563) provided comments to the free-text question. Respondents made more positive comments than negative comments. Four common themes were identified: feeling seen, heard, and cared for; the information received filled the gap and sometimes missed the mark; service organization and follow-up: smooth for some, frustrating for others; and, accessing care: virtual options, travel burden, and waiting.

Conclusion

This analysis highlights the positive effect of receiving clear information and having a respectful patient-provider relationship on patients' perceived quality of care. Conversely, the need for alternative consultation-delivery modes, such as virtual care, was identified as an area of opportunity to improve patients’ care experience.
背景:影响患者满意度和对综合血栓和抗凝治疗服务质量感知的患者经历信息有限。然而,为了提供以患者为中心的护理,患者的投入是至关重要的。因此,我们旨在探讨在成人门诊血栓服务中心接受治疗的人的观点和经验,以确定有价值的方面以及需要改进的领域。方法:这是对2017年10月至2019年5月期间在加拿大纽芬兰和拉布拉多多学科血栓形成服务中心接受治疗的所有成年患者的匿名调查的自由文本数据的分析。主题分析用于分析开放式自由文本回答并确定共同主题。总共有40.7% (n = 229)的调查对象(n = 563)对自由文本问题提供了评论。受访者给出的正面评价多于负面评价。确定了四个共同的主题:感觉被看到、被听到和被关心;接收到的信息填补了空白,有时会漏掉目标;服务组织与跟进:有的顺利,有的不顺;获得医疗服务:虚拟选择、旅行负担和等待。结论本分析突出了接收清晰的信息和建立尊重的医患关系对患者感知护理质量的积极影响。相反,对替代咨询交付模式的需求,如虚拟护理,被确定为改善患者护理体验的机会领域。
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引用次数: 0
Thrombin generation remains stable in frozen plasma over long-term storage 凝血酶的生成在冷冻血浆中长期保存是稳定的
Q4 Medicine Pub Date : 2025-07-12 DOI: 10.1016/j.tru.2025.100216
A. Carlo , R. de Laat-Kremers , B. de Laat , M. Ninivaggi

Background

The ST Genesia is a fully automated thrombin generation (TG) device. Measuring TG can be useful for medical purposes as it is an indicator for the bleeding or thrombotic risk of a patient. When measuring TG, it is of utmost importance to be careful with the preanalytical part as it can affect TG. One of the preanalytical steps to be cautious with, is the plasma sample storage temperature and duration.

Methods

Citrated blood was collected and centrifuged twice for 10 min at 2840g to obtain platelet poor plasma. Plasma samples were stored directly in the freezer either at −20 °C or at −80 °C. TG was measured with a low, intermediate and high tissue factor concentration (STG-BleedScreen, STG-ThromboScreen and STG-DrugScreen, respectively) in fresh samples and after storage at -20°C and -80°C for 1 day, 1 month, 3 months, 6 months and 12 months. The samples stored at −80 °C were also measured after 18 and 24 months.

Results

Freezing platelet poor plasma samples did affect the TG parameters. This observation was independent of the storage temperature and the tissue factor used for triggering TG. Interestingly, TG was not significantly affected by time in storage at −20 °C and −80 °C even up to one year or two years, respectively. Some variation was observed in the samples measured with thrombomodulin, which may have been due to the use of a reagent kit with different lot number.

Conclusion

Freezing plasma does affect TG independently of the storage temperature. However, once frozen, the TG does not vary significantly in time even up to one or two years for samples stored at −20 °C and −80 °C, respectively.
ST Genesia是一种全自动凝血酶生成(TG)设备。测量TG可用于医疗目的,因为它是一个指标出血或血栓形成的风险的病人。当测量TG时,最重要的是要小心分析前部分,因为它会影响TG。分析前需要注意的一个步骤是血浆样品的储存温度和持续时间。方法采集静血,2840g离心2次,10 min,获得血小板差血浆。血浆样品直接保存在- 20°C或- 80°C的冷冻室中。在新鲜样品和在-20°C和-80°C保存1天、1个月、3个月、6个月和12个月后,分别采用低、中、高组织因子浓度(分别为stg - bleeding screen、STG-ThromboScreen和STG-DrugScreen)测量TG。在- 80°C保存的样品也在18个月和24个月后进行测量。结果冻结血小板含量低的血浆样品对TG参数有影响。这一观察结果与储存温度和触发TG的组织因子无关。有趣的是,TG分别在- 20°C和- 80°C下保存一年和两年,并没有受到时间的显著影响。在用血栓调节素测量的样品中观察到一些变化,这可能是由于使用了不同批号的试剂盒。结论血浆冷冻对TG的影响与贮藏温度无关。然而,一旦冻结,即使在- 20°C和- 80°C分别储存的样品长达一年或两年,TG也不会随时间发生显着变化。
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引用次数: 0
Reduction in D-dimer levels after treatment with Auxora in patients with severe COVID-19 pneumonia 重症COVID-19肺炎患者用Auxora治疗后d -二聚体水平降低
Q4 Medicine Pub Date : 2025-07-11 DOI: 10.1016/j.tru.2025.100217
Peter C. Hou , Joseph Miller , Charles Bruen , Fady Youssef , Michael J. Schnaus , Kathyrn Brouillette , Raul Mendoza-Ayala , Jeffrey Zhang , Kenneth Stauderman , Sudarshan Hebbar

Introduction

A phase 2 double-blinded trial (CARDEA) (NCT04345614) in patients diagnosed with COVID-19 revealed that intravenous zegocractin treatment (Auxora™) was associated with improved clinical outcomes compared to standard of care (SOC). D-dimer serum level is a biomarker of thrombosis in COVID-19, and elevated levels are directly correlated with a high risk of poor outcomes. Here, we report biomarker analyses from blood samples collected from patients in that study.

Methods

Quantification of D-dimer levels was the primary endpoint of the study. Secondary endpoints measured levels of angiopoietin 1 (Ang1), angiopoietin 2 (Ang2), soluble CD25 (sCD25), and renin. CARDEA was conducted in 17 U S. clinical centers. Patients were randomly assigned to receive Auxora plus SOC (n = 143) or placebo plus SOC (n = 141). The medications were administered by a 4-h intravenous infusion at 2.0 mg/kg (1.25 mL/kg) at 0-h and 1.6 mg/kg (1 mL/kg) at 24 h and 48 h.

Findings

Patients in the Auxora group had a baseline mean D-dimer value of 2.61 mg/L and those in the placebo group had a value of 2.05 mg/L. Treatment with Auxora resulted in a statistically significant decrease in D-dimer levels within the first 72 h compared to placebo (delta = −0.92; [95 % CI: −1.82, −0.02]; p < 0.046). The decrease in D-dimer levels correlated with an increase in imputed PaO2/FiO2 at 72 h (r: −0.193; p < 0.05) and improved clinical status at 168 h (r: 0.218, p < 0.01). Auxora treatment reduced levels of Ang2 and sCD25, and increased Ang1 levels compared to placebo.

Conclusion

Auxora treatment significantly reduced D-dimer levels in patients diagnosed with COVID-19, and the decrease was associated with an improved clinical status.
一项针对COVID-19患者的2期双盲试验(CARDEA) (NCT04345614)显示,与标准治疗(SOC)相比,静脉注射zegocractin治疗(Auxora™)可改善临床结果。血清d -二聚体水平是COVID-19血栓形成的生物标志物,水平升高与预后不良的高风险直接相关。在这里,我们报告了从该研究中收集的患者血液样本中的生物标志物分析。方法d -二聚体水平的量化是研究的主要终点。次要终点测量血管生成素1 (Ang1)、血管生成素2 (Ang2)、可溶性CD25 (sCD25)和肾素水平。CARDEA在美国17个临床中心进行。患者被随机分配接受Auxora + SOC (n = 143)或安慰剂+ SOC (n = 141)。通过静脉滴注4小时给药,0小时2.0 mg/kg (1.25 mL/kg), 24小时和48小时1.6 mg/kg (1 mL/kg)。结果:Auxora组患者的基线平均d -二聚体值为2.61 mg/L,安慰剂组患者的基线平均d -二聚体值为2.05 mg/L。与安慰剂相比,Auxora治疗导致前72小时内d -二聚体水平有统计学意义的下降(δ = - 0.92;[95% ci:−1.82,−0.02];p & lt;0.046)。d -二聚体水平的降低与72 h时估算PaO2/FiO2的增加相关(r: - 0.193;p & lt;0.05), 168 h临床状态改善(r: 0.218, p <;0.01)。与安慰剂相比,Auxora治疗降低了Ang2和sCD25水平,并增加了Ang1水平。结论auxora治疗可显著降低COVID-19患者的d -二聚体水平,且与临床状况改善相关。
{"title":"Reduction in D-dimer levels after treatment with Auxora in patients with severe COVID-19 pneumonia","authors":"Peter C. Hou ,&nbsp;Joseph Miller ,&nbsp;Charles Bruen ,&nbsp;Fady Youssef ,&nbsp;Michael J. Schnaus ,&nbsp;Kathyrn Brouillette ,&nbsp;Raul Mendoza-Ayala ,&nbsp;Jeffrey Zhang ,&nbsp;Kenneth Stauderman ,&nbsp;Sudarshan Hebbar","doi":"10.1016/j.tru.2025.100217","DOIUrl":"10.1016/j.tru.2025.100217","url":null,"abstract":"<div><h3>Introduction</h3><div>A phase 2 double-blinded trial (CARDEA) (<span><span>NCT04345614</span><svg><path></path></svg></span>) in patients diagnosed with COVID-19 revealed that intravenous zegocractin treatment (Auxora™) was associated with improved clinical outcomes compared to standard of care (SOC). D-dimer serum level is a biomarker of thrombosis in COVID-19, and elevated levels are directly correlated with a high risk of poor outcomes. Here, we report biomarker analyses from blood samples collected from patients in that study.</div></div><div><h3>Methods</h3><div>Quantification of D-dimer levels was the primary endpoint of the study. Secondary endpoints measured levels of angiopoietin 1 (Ang1), angiopoietin 2 (Ang2), soluble CD25 (sCD25), and renin. CARDEA was conducted in 17 U S. clinical centers. Patients were randomly assigned to receive Auxora plus SOC (n = 143) or placebo plus SOC (n = 141). The medications were administered by a 4-h intravenous infusion at 2.0 mg/kg (1.25 mL/kg) at 0-h and 1.6 mg/kg (1 mL/kg) at 24 h and 48 h.</div></div><div><h3>Findings</h3><div>Patients in the Auxora group had a baseline mean D-dimer value of 2.61 mg/L and those in the placebo group had a value of 2.05 mg/L. Treatment with Auxora resulted in a statistically significant decrease in D-dimer levels within the first 72 h compared to placebo (delta = −0.92; [95 % CI: −1.82, −0.02]; <em>p</em> &lt; 0.046). The decrease in D-dimer levels correlated with an increase in imputed PaO<sub>2</sub>/FiO<sub>2</sub> at 72 h (r: −0.193; <em>p</em> &lt; 0.05) and improved clinical status at 168 h (r: 0.218, <em>p</em> &lt; 0.01). Auxora treatment reduced levels of Ang2 and sCD25, and increased Ang1 levels compared to placebo.</div></div><div><h3>Conclusion</h3><div>Auxora treatment significantly reduced D-dimer levels in patients diagnosed with COVID-19, and the decrease was associated with an improved clinical status.</div></div>","PeriodicalId":34401,"journal":{"name":"Thrombosis Update","volume":"20 ","pages":"Article 100217"},"PeriodicalIF":0.0,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144653782","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Characterizing anticoagulation reversal practices in Colombia: Initial insights from a national registry 哥伦比亚抗凝逆转实践的特征:来自国家登记的初步见解
Q4 Medicine Pub Date : 2025-07-01 DOI: 10.1016/j.tru.2025.100215
Sebastián Seni-Molina , Santiago Posso Marín , Juan Esteban Masmela , María Camila Naranjo-Ramírez , Arturo D. Mora , Juliana María Gutiérrez-Posso , Julio Diez-Sepúlveda , Juan David Victoria-Salcedo , Ana Cristina Montenegro Arenas , Camilo Andrés Rueda Ortiz , Edgar David Gómez Lahitton , Hoover O. León-Giraldo , Juan Esteban Gómez-Mesa , On behalf of the RECCANT-AR Research Group

Background

Anticoagulation reversal is critical in emergency settings for patients experiencing anticoagulant-related bleeding or requiring invasive or surgical procedures. Despite its importance, evidence in Colombia is limited.

Methods

RECCANT-AR (Registro Colombiano de Clínicas de Anticoagulación y el Uso de Agentes Reversores) is a multicenter, observational, ambispective study analyzing anticoagulated patients requiring reversal therapy due to bleeding or procedural needs. Data from the first 144 patients across four institutions were analyzed to describe their sociodemographic and clinical profiles.

Results

The cohort had a mean age of 66.9 years (SD ± 15.3) and a nearly equal sex distribution. Ethnicity was predominantly Mestizo (67.5%), followed by White (17.5%) and Afrodescendant (13.3%). The most common comorbidities were hypertension (61.8%), previous venous thromboembolism episodes (31.3%), dyslipidemia (30.6%), and diabetes mellitus (21.5%). Warfarin was the predominant anticoagulant (84%), followed by apixaban (4.9%) and dabigatran (4.2%). Bleeding was the primary indication for reversal (92.4%), while surgical needs accounted for 7.6% of cases. The most used reversal agents were vitamin K (75%) and prothrombin complex concentrates (27.1%). Hospitalization was required in 82% of cases, with 55.1% admitted to intensive care. The mortality rate was 7.6%.

Conclusion

Our study is the first multicenter characterization of anticoagulated patients requiring reversal therapy in Colombia. Cardiovascular comorbidities were highly prevalent, highlighting their association with hemorrhagic complications. Bleeding was the leading indication for reversal, and warfarin the most used anticoagulant, likely reflecting its higher bleeding risk. The limited availability of direct oral anticoagulant-specific reversal agents remains a challenge. The high hospitalization and mortality rates underscore the high-risk nature of this population, emphasizing the need for improved access to reversal agents and optimized anticoagulation practices. Further research is warranted.
背景:抗凝逆转在紧急情况下对于经历抗凝相关出血或需要侵入性或外科手术的患者至关重要。尽管它很重要,但在哥伦比亚的证据有限。recant - ar (Registro Colombiano de Clínicas de Anticoagulación y el Uso de Agentes Reversores)是一项多中心、观察性、双视角研究,分析因出血或手术需要而需要逆转治疗的抗凝患者。研究人员分析了来自四家机构的首批144名患者的数据,以描述他们的社会人口统计学和临床概况。结果该队列平均年龄为66.9岁(SD±15.3),性别分布基本相等。种族主要是混血儿(67.5%),其次是白人(17.5%)和非洲后裔(13.3%)。最常见的合并症是高血压(61.8%),既往静脉血栓栓塞发作(31.3%),血脂异常(30.6%)和糖尿病(21.5%)。华法林是最主要的抗凝剂(84%),其次是阿哌沙班(4.9%)和达比加群(4.2%)。出血是逆转的主要指征(92.4%),而手术需要占7.6%。使用最多的逆转药物是维生素K(75%)和凝血酶原复合物浓缩物(27.1%)。82%的病例需要住院治疗,55.1%的病例需要接受重症监护。死亡率为7.6%。结论:我们的研究是哥伦比亚首个对需要逆转治疗的抗凝患者进行多中心表征的研究。心血管合并症非常普遍,突出了它们与出血性并发症的关联。出血是逆转的主要指征,华法林是最常用的抗凝剂,可能反映了其较高的出血风险。直接口服抗凝特异性逆转药物的有限可用性仍然是一个挑战。高住院率和死亡率强调了这一人群的高风险性质,强调了改善获得逆转药物和优化抗凝实践的必要性。进一步的研究是有必要的。
{"title":"Characterizing anticoagulation reversal practices in Colombia: Initial insights from a national registry","authors":"Sebastián Seni-Molina ,&nbsp;Santiago Posso Marín ,&nbsp;Juan Esteban Masmela ,&nbsp;María Camila Naranjo-Ramírez ,&nbsp;Arturo D. Mora ,&nbsp;Juliana María Gutiérrez-Posso ,&nbsp;Julio Diez-Sepúlveda ,&nbsp;Juan David Victoria-Salcedo ,&nbsp;Ana Cristina Montenegro Arenas ,&nbsp;Camilo Andrés Rueda Ortiz ,&nbsp;Edgar David Gómez Lahitton ,&nbsp;Hoover O. León-Giraldo ,&nbsp;Juan Esteban Gómez-Mesa ,&nbsp;On behalf of the RECCANT-AR Research Group","doi":"10.1016/j.tru.2025.100215","DOIUrl":"10.1016/j.tru.2025.100215","url":null,"abstract":"<div><h3>Background</h3><div>Anticoagulation reversal is critical in emergency settings for patients experiencing anticoagulant-related bleeding or requiring invasive or surgical procedures. Despite its importance, evidence in Colombia is limited.</div></div><div><h3>Methods</h3><div>RECCANT-AR (<strong><em>Re</em></strong><em>gistro</em> <strong><em>C</em></strong><em>olombiano de</em> <strong><em>C</em></strong><em>línicas de</em> <strong><em>Ant</em></strong><em>icoagulación y el Uso de</em> <strong><em>A</em></strong><em>gentes</em> <strong><em>R</em></strong><em>eversores</em>) is a multicenter, observational, ambispective study analyzing anticoagulated patients requiring reversal therapy due to bleeding or procedural needs. Data from the first 144 patients across four institutions were analyzed to describe their sociodemographic and clinical profiles.</div></div><div><h3>Results</h3><div>The cohort had a mean age of 66.9 years (SD ± 15.3) and a nearly equal sex distribution. Ethnicity was predominantly Mestizo (67.5%), followed by White (17.5%) and Afrodescendant (13.3%). The most common comorbidities were hypertension (61.8%), previous venous thromboembolism episodes (31.3%), dyslipidemia (30.6%), and diabetes mellitus (21.5%). Warfarin was the predominant anticoagulant (84%), followed by apixaban (4.9%) and dabigatran (4.2%). Bleeding was the primary indication for reversal (92.4%), while surgical needs accounted for 7.6% of cases. The most used reversal agents were vitamin K (75%) and prothrombin complex concentrates (27.1%). Hospitalization was required in 82% of cases, with 55.1% admitted to intensive care. The mortality rate was 7.6%.</div></div><div><h3>Conclusion</h3><div>Our study is the first multicenter characterization of anticoagulated patients requiring reversal therapy in Colombia. Cardiovascular comorbidities were highly prevalent, highlighting their association with hemorrhagic complications. Bleeding was the leading indication for reversal, and warfarin the most used anticoagulant, likely reflecting its higher bleeding risk. The limited availability of direct oral anticoagulant-specific reversal agents remains a challenge. The high hospitalization and mortality rates underscore the high-risk nature of this population, emphasizing the need for improved access to reversal agents and optimized anticoagulation practices. Further research is warranted.</div></div>","PeriodicalId":34401,"journal":{"name":"Thrombosis Update","volume":"20 ","pages":"Article 100215"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144766902","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Venous and arterial thromboembolism in out-patients with inflammatory bowel disease: a single center study 炎症性肠病患者门诊静脉和动脉血栓栓塞:一项单中心研究
Q4 Medicine Pub Date : 2025-06-04 DOI: 10.1016/j.tru.2025.100212
Antonella Tufano , Anna Testa , Marta Patturelli, Antonio Rispo, Vincenzo Fotticchia, Paola Rufolo, Federica Strano, Alessia Dalila Guarino, Antonietta Vitale, Olga Maria Nardone, Mario Ferrante, Rossella Caso, Fabiana Castiglione

Background

Patients affected by inflammatory bowel diseases (IBD), namely Crohn's disease (CD) and ulcerative colitis (UC), are at risk for thromboembolic events (TE). Patients with active/relapsing disease and those needing hospitalization and surgery show the highest risk. The thrombotic risk in out-patients with IBD is underestimated and poorly investigated.

Objectives

to evaluate the prevalence, clinical features and risk factors for thromboembolism in IBD out-patients.

Methods

From May 2021 to September 2023, consecutive IBD out-patients were evaluated for the presence of cardiovascular risk factors (smoking, arterial hypertension, diabetes mellitus, hypercholesterolemia) and history of TE. Patients with a history of TE (including coronary heart disease, stroke, transient ischemic attack- TIA-, deep vein thrombosis- DVT-, superficial vein thrombosis- SVT-, pulmonary embolism- PE-) were studied for thrombophilia.

Results

A total of 302 IBD outpatients were included in the study (154 CD; 148 UC; mean age: 41.23 ± 17.4 years). Twenty-three patients (23/302; 7.6 %) showed a thrombotic event: 14 UC patients (14/148; 9.4 %) and 9 CD patients (9/154; 5.8 %).
Among the 23 patients with TE, we observed 12 arterial thromboses (12/23; 52.2 %), including 7 cases of Myocardial Infarction (7/12; 58.3 %), 3 Ischemic Stroke (3/12; 25 %), 2 TIA (2/12; 16.7 %); and 11 episodes of venous thromboembolism (VTE) (11/23; 47.8 %), including 7 DVT (7/11; 63.6 %), 2 SVT (2/11; 18.2 %) and 2 PE (2/11; 18.2 %).
Among the 11 VTE patients 6 were affected by UC and 5 patients were affected by CD. 5 out of 12 arterial thrombosis patients were affected by CD and 7 patients by UC.
In the univariable analysis, several predictors showed a significant association with TE, including IBD activity (OR = 4.98, 95 % CI: 1.93–12.81), arterial hypertension (OR = 4.44, 95 % CI: 1.86–10.60), hypercholesterolemia (OR = 4.68, 95 % CI: 1.38–15.92), hematologic disease (OR = 6.55, 95 % CI: 1.13–37.85).
IBD activity (OR = 7.03, 95 % CI: 2.48–19.85), arterial hypertension (OR = 3.35, 95 % CI: 1.32–8.50), hypercholesterolemia (OR = 5.06, 95 % CI: 1.21–18.77), hematologic disease (OR = 12.58, 95 % CI: 1.87–69.87) and immune disease (OR = 19.39, 95 % CI: 1.29–289.60) were significantly correlated to TE events at multivariable analysis.

Conclusions

Out-patients with IBD presented a low but not negligible risk of TE, mainly correlated to the common cardiovascular risk factors described in the general population and to the presence of immunological and hematological disease. Clinicians should not underestimate thrombotic risk in these patients.
受炎症性肠病(IBD)影响的患者,即克罗恩病(CD)和溃疡性结肠炎(UC),具有血栓栓塞事件(TE)的风险。活动性/复发性疾病患者和需要住院和手术的患者风险最高。IBD门诊患者的血栓形成风险被低估且调查不足。目的了解IBD门诊患者血栓栓塞的患病率、临床特点及危险因素。方法对2021年5月至2023年9月连续IBD门诊患者进行心血管危险因素(吸烟、动脉高血压、糖尿病、高胆固醇血症)和TE病史的评估。对有TE病史(包括冠心病、卒中、短暂性脑缺血发作- TIA-、深静脉血栓形成- DVT-、浅静脉血栓形成- SVT-、肺栓塞- PE-)的患者进行血栓倾向研究。结果共有302例IBD门诊患者纳入研究(154例CD;148年加州大学;平均年龄:41.23±17.4岁)。23例患者(23/302;7.6%)显示血栓形成事件:14例UC患者(14/148;9.4%)和9例CD患者(9/154;5.8%)。在23例TE患者中,我们观察到12例动脉血栓形成(12/23;52.2%),其中心肌梗死7例(7/12;58.3%),缺血性卒中3例(3/12;25%), 2 tia (2/12;16.7%);11次静脉血栓栓塞(VTE)发作(11/23;47.8%),包括7例DVT (7/11;63.6%), 2 SVT (2/11;18.2%)和2个PE (2/11;18.2%)。11例VTE患者中有6例合并UC, 5例合并CD。12例动脉血栓患者中有5例合并CD, 7例合并UC。在单变量分析中,几个预测因素显示与TE有显著关联,包括IBD活动性(OR = 4.98, 95% CI: 1.93-12.81)、动脉高血压(OR = 4.44, 95% CI: 1.86-10.60)、高胆固醇血症(OR = 4.68, 95% CI: 1.38-15.92)、血液病(OR = 6.55, 95% CI: 1.13-37.85)。在多变量分析中,IBD活性(OR = 7.03, 95% CI: 2.48-19.85)、动脉高血压(OR = 3.35, 95% CI: 1.32-8.50)、高胆固醇血症(OR = 5.06, 95% CI: 1.21-18.77)、血清学疾病(OR = 12.58, 95% CI: 1.87-69.87)和免疫疾病(OR = 19.39, 95% CI: 1.29-289.60)与TE事件显著相关。结论IBD门诊患者TE风险低但不可忽视,主要与普通人群中常见的心血管危险因素以及免疫和血液系统疾病的存在相关。临床医生不应低估这些患者的血栓形成风险。
{"title":"Venous and arterial thromboembolism in out-patients with inflammatory bowel disease: a single center study","authors":"Antonella Tufano ,&nbsp;Anna Testa ,&nbsp;Marta Patturelli,&nbsp;Antonio Rispo,&nbsp;Vincenzo Fotticchia,&nbsp;Paola Rufolo,&nbsp;Federica Strano,&nbsp;Alessia Dalila Guarino,&nbsp;Antonietta Vitale,&nbsp;Olga Maria Nardone,&nbsp;Mario Ferrante,&nbsp;Rossella Caso,&nbsp;Fabiana Castiglione","doi":"10.1016/j.tru.2025.100212","DOIUrl":"10.1016/j.tru.2025.100212","url":null,"abstract":"<div><h3>Background</h3><div>Patients affected by inflammatory bowel diseases (IBD), namely Crohn's disease (CD) and ulcerative colitis (UC), are at risk for thromboembolic events (TE). Patients with active/relapsing disease and those needing hospitalization and surgery show the highest risk. The thrombotic risk in out-patients with IBD is underestimated and poorly investigated.</div></div><div><h3>Objectives</h3><div>to evaluate the prevalence, clinical features and risk factors for thromboembolism in IBD out-patients.</div></div><div><h3>Methods</h3><div>From May 2021 to September 2023, consecutive IBD out-patients were evaluated for the presence of cardiovascular risk factors (smoking, arterial hypertension, diabetes mellitus, hypercholesterolemia) and history of TE. Patients with a history of TE (including coronary heart disease, stroke, transient ischemic attack- TIA-, deep vein thrombosis- DVT-, superficial vein thrombosis- SVT-, pulmonary embolism- PE-) were studied for thrombophilia.</div></div><div><h3>Results</h3><div>A total of 302 IBD outpatients were included in the study (154 CD; 148 UC; mean age: 41.23 ± 17.4 years). Twenty-three patients (23/302; 7.6 %) showed a thrombotic event: 14 UC patients (14/148; 9.4 %) and 9 CD patients (9/154; 5.8 %).</div><div>Among the 23 patients with TE, we observed 12 arterial thromboses (12/23; 52.2 %), including 7 cases of Myocardial Infarction (7/12; 58.3 %), 3 Ischemic Stroke (3/12; 25 %), 2 TIA (2/12; 16.7 %); and 11 episodes of venous thromboembolism (VTE) (11/23; 47.8 %), including 7 DVT (7/11; 63.6 %), 2 SVT (2/11; 18.2 %) and 2 PE (2/11; 18.2 %).</div><div>Among the 11 VTE patients 6 were affected by UC and 5 patients were affected by CD. 5 out of 12 arterial thrombosis patients were affected by CD and 7 patients by UC.</div><div>In the univariable analysis, several predictors showed a significant association with TE, including IBD activity (OR = 4.98, 95 % CI: 1.93–12.81), arterial hypertension (OR = 4.44, 95 % CI: 1.86–10.60), hypercholesterolemia (OR = 4.68, 95 % CI: 1.38–15.92), hematologic disease (OR = 6.55, 95 % CI: 1.13–37.85).</div><div>IBD activity (OR = 7.03, 95 % CI: 2.48–19.85), arterial hypertension (OR = 3.35, 95 % CI: 1.32–8.50), hypercholesterolemia (OR = 5.06, 95 % CI: 1.21–18.77), hematologic disease (OR = 12.58, 95 % CI: 1.87–69.87) and immune disease (OR = 19.39, 95 % CI: 1.29–289.60) were significantly correlated to TE events at multivariable analysis.</div></div><div><h3>Conclusions</h3><div>Out-patients with IBD presented a low but not negligible risk of TE, mainly correlated to the common cardiovascular risk factors described in the general population and to the presence of immunological and hematological disease. Clinicians should not underestimate thrombotic risk in these patients.</div></div>","PeriodicalId":34401,"journal":{"name":"Thrombosis Update","volume":"20 ","pages":"Article 100212"},"PeriodicalIF":0.0,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144711545","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Optimizing end of life care in cancer Patients. Focus on antithrombotic treatment 优化癌症患者的临终关怀。关注抗血栓治疗
Q4 Medicine Pub Date : 2025-06-01 DOI: 10.1016/j.tru.2025.100213
Emmanouil S. Papadakis, Lucy A. Norris
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引用次数: 0
Clinical outcomes of direct oral anticoagulant off-label dosing in nonvalvular atrial fibrillation 非瓣膜性房颤直接口服超说明书剂量抗凝药物的临床疗效
Q4 Medicine Pub Date : 2025-05-22 DOI: 10.1016/j.tru.2025.100210
M. Jansson , S. Själander , V. Sjögren , F. Björck , H. Renlund , A. Själander

Introduction

Direct oral anticoagulants (DOACs) used in nonvalvular atrial fibrillation (NVAF) are superior or non-inferior to warfarin in reducing the risk of stroke while at the same time having a similar or lower risk of bleeding. However, reduced doses are prescribed more often than expected from clinical practice and off-label underdosing is a frequent issue. The objective of this study was to compare effectiveness and safety between guideline and off-label dosing of DOACs.

Materials and methods

Auricula, a Swedish anticoagulation registry was used in identifying eligible patients from July 2011 to December 2017. The study cohort consisted of 47,355 patients with newly initiated DOAC (apixaban, dabigatran, or rivaroxaban) after exclusion of 92,316 patients due to concomitant venous thromboembolism, previous mechanical heart valve (MHV) or previous data entry in Auricula. The median durations of follow up were 403, 419, 373 and 209 days in the on-label standard dose cohort, off-label reduced dose cohort, on-label reduced dose cohort and the off-label standard dose cohort respectively. Endpoints (stroke and major bleeding) and baseline characteristics were collected from hospital administrative registers using ICD-10 codes or the Swedish Stroke register. Cohorts were compared using weighted adjusted Cox regression after full optimal matching based on propensity scores.

Results

Off-label underdosing of DOACs (n = 6,187, 9.7 %) was associated with higher risk of major bleeding HR 1.16 (95 % CI 1.05–1.27), other bleeding HR 1.16 (1.04–1.30), myocardial infarction HR 1.47 (1.20–1.80), ischemic stroke HR 1.25 (1.04–1.50) and all-cause mortality HR 1.52 (1.37–1.69) compared to on-label standard dosing (n = 35,065, 55.2 %). Among off-label underdosed DOACs, dabigatran was associated with higher risk of all-cause stroke 1.86 (1.07–3.23), ischemic stroke HR 1.97 (1.10–3.52) and all-cause stroke and systemic embolism HR 1.92 (1.11–3.32) compared to apixaban. Rivaroxaban was associated with major bleeding HR 1.70 (1.41–2.03), gastrointestinal bleeding HR 1.92 (1.33–2.77), and other bleeding HR 1.97 (1.57–2.47) compared to apixaban. The study could not show any differences comparing off-label overdosing of DOACs and on-label reduced dosing, besides lower risk of all-cause mortality HR 0.69 (0.52–0.93) in the overdosed patients.

Conclusions

In this large observational registry-based NVAF cohort, underdosing of DOACs is associated with higher risk of ischemic and all-cause stroke but also major bleeding when compared to on-label dosing. Underlying DOAC therapy may need to be tailored to the specific patient when choosing off-label reduced dosing since underdosed rivaroxaban is associated with higher risk of bleeding complications, and underdosed dabigatran is associated with higher risk of stroke complications, when comparing both with apixaban.
直接口服抗凝剂(DOACs)用于非瓣膜性房颤(NVAF)在降低卒中风险方面优于或不低于华法林,同时出血风险相似或更低。然而,减少剂量的处方比临床实践中预期的要多,并且标签外剂量不足是一个常见的问题。本研究的目的是比较指南和说明书外剂量的doac的有效性和安全性。材料和方法:2011年7月至2017年12月,使用瑞典抗凝登记系统sauricula确定符合条件的患者。该研究队列包括47,355例新开始DOAC(阿哌沙班、达比加群或利伐沙班)的患者,排除了92,316例因合并静脉血栓栓塞、既往机械心脏瓣膜(MHV)或既往在Auricula中输入数据的患者。标签上标准剂量组、标签外减少剂量组、标签上减少剂量组和标签外标准剂量组的中位随访时间分别为403、419、373和209天。终点(中风和大出血)和基线特征收集自使用ICD-10代码或瑞典中风登记的医院行政登记册。在基于倾向得分的完全最优匹配后,使用加权调整Cox回归对队列进行比较。结果与标签上的标准剂量(n = 35,065, 55.2%)相比,标签上的DOACs剂量不足(n = 6,187, 9.7%)与主要出血(HR 1.16, 95% CI 1.05-1.27)、其他出血(HR 1.16, 1.04-1.30)、心肌梗死(HR 1.47, 1.20-1.80)、缺血性卒中(HR 1.25, 1.04-1.50)和全因死亡率(HR 1.52, 1.37-1.69)相关。在标签外用药不足的doac中,与阿哌沙班相比,达比加群的全因卒中风险为1.86(1.07-3.23),缺血性卒中风险为1.97(1.10-3.52),全因卒中和全身栓塞风险为1.92(1.11-3.32)。与阿哌沙班相比,利伐沙班与大出血相关的HR为1.70(1.41-2.03),胃肠道出血相关HR为1.92(1.33-2.77),其他出血相关HR为1.97(1.57-2.47)。该研究并没有显示DOACs的标签外过量和标签内减少剂量的差异,除了过量患者的全因死亡风险较低HR 0.69(0.52-0.93)。结论:在这个基于登记的大型非瓣膜性房颤观察队列中,与标签上的剂量相比,DOACs的剂量不足与缺血性和全因卒中的风险增加有关,但也与大出血有关。当选择标签外减少剂量时,潜在的DOAC治疗可能需要针对特定患者进行定制,因为与阿哌沙班相比,利伐沙班剂量不足与出血并发症的高风险相关,达比加群剂量不足与卒中并发症的高风险相关。
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引用次数: 0
Antithrombin supplementation to prevent venous thromboembolism: A case of hereditary antithrombin deficiency with increased antithrombin clearance during pregnancy and peripartum 补充抗凝血酶预防静脉血栓栓塞:一例遗传性抗凝血酶缺乏症在妊娠和围产期抗凝血酶清除率增高
Q4 Medicine Pub Date : 2025-05-20 DOI: 10.1016/j.tru.2025.100211
Ayako Kaneda-Takeuchi , Tomoaki Oda , Mei Kitamoto , Emiyu Fujiwara , Kenta Kawai , Megumi Narumi , Yoshimasa Horikoshi , Masako Matsumoto , Yukiko Kohmura-Kobayashi , Naomi Furuta-Isomura , Toshiyuki Uchida , Kazunao Suzuki , Naohiro Kanayama , Hiroaki Itoh , Naoaki Tamura
Hereditary antithrombin deficiency (HATD) is an autosomal dominant disorder that significantly increases the risk of venous thromboembolism (VTE) during pregnancy. Based on our experience with three previous cases and the Japanese clinical guidelines, we manage high-risk VTE in pregnant women with HATD using unfractionated heparin (UFH) and antithrombin (AT) supplementation from early pregnancy to the peripartum period. Herein, we report another case of HATD type 1 in pregnancy and evaluate changes in AT clearance. A 29-year-old woman had a history of pulmonary embolism (PE) at 14 years and a family history of HATD with AT activity of 47 % at baseline, which decreased to 31 % when she developed PE after an abortion. During her second pregnancy, she was treated with UFH and AT concentrate (ATC) with doses increasing from 50 to 100 IU/kg to achieve target AT activity levels of 50–60 % throughout pregnancy and 70 % during delivery. She delivered a healthy male infant at 39 weeks of gestation. She started to take warfarin on postpartum day 1, with an uneventful postpartum course. AT clearance, calculated using plasma AT antigen levels, showed notable increases in the first and late third trimesters, peaking around delivery and coinciding with elevated thrombin-antithrombin complex levels. These findings suggest increased AT consumption during these periods, which may contribute to unexpected decreases in AT activity. We propose close monitoring of AT activity and providing adequate ATC supplementation alongside anticoagulation throughout pregnancy, particularly during periods of elevated AT clearance, to minimize VTE risks in HATD patients.
遗传性抗凝血酶缺乏症(HATD)是一种常染色体显性遗传病,可显著增加妊娠期间静脉血栓栓塞(VTE)的风险。根据我们之前三个病例的经验和日本临床指南,我们从妊娠早期到围产期使用未分级肝素(UFH)和抗凝血酶(AT)补充治疗患有HATD的孕妇的高危静脉血栓栓塞。在此,我们报告另一例妊娠期HATD 1型,并评估AT清除率的变化。一名29岁女性,14岁时有肺栓塞(PE)史,有HATD家族史,at活性基线时为47%,流产后发生PE后降至31%。在她第二次怀孕期间,她接受UFH和AT浓缩物(ATC)治疗,剂量从50增加到100 IU/kg,以达到整个怀孕期间50 - 60%和分娩期间70%的AT活性目标水平。她在怀孕39周时生下了一个健康的男婴。她在产后第一天开始服用华法林,在产后过程中一切顺利。使用血浆AT抗原水平计算的AT清除率显示,在妊娠早期和晚期显著增加,在分娩前后达到峰值,并与凝血酶-抗凝血酶复合物水平升高相吻合。这些发现表明,在这些时期,AT消耗增加,这可能导致AT活动意想不到的减少。我们建议密切监测AT活性,并在整个妊娠期间,特别是AT清除率升高期间,在抗凝治疗的同时补充足够的ATC,以最大限度地降低HATD患者的静脉血栓栓塞风险。
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引用次数: 0
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Thrombosis Update
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